A Multiple-Dose Study of Oral Oseltamivir in Participants on Hemodialysis (HD) and Continuous Ambulatory Peritoneal Dialysis (CAPD)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-10-31

Study Completion Date

2002-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is designed to assess the pharmacokinetics (PK) and safety of oseltamivir and its metabolite oseltamivir carboxylate in participants undergoing routine HD and CAPD for end-stage renal disease (ESRD). Participants will receive 6.5 and 6 weeks of the marketed oral oseltamivir suspension dosed according to the HD or CAPD schedule, respectively.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Pharmacokinetics of Tamiflu® (Oseltamivir) in Patients Receiving Extracorporeal Membrane Oxygenation (ECMO)and or Continuous Venovenous Hemodialysis (CVVHD)

NCT01048879

Critically Ill Renal Failure Requiring CVVHD and Oseltamivir Critically Ill Requiring ECMO and Oseltamivir

COMPLETED PHASE4

A Study to Evaluate the Safety and Pharmacokinetics of BMS-986177 in Participants With End-stage Renal Dysfunction on Chronic Stable Hemodialysis Treatment

NCT02902679

Thrombosis Factor XI Renal Impairment +1 more

COMPLETED PHASE1

Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of INCB054707 in Participants With Normal and Impaired Renal Function and Participants on Hemodialysis

NCT05624723

Renal Insufficiency Kidney Diseases

COMPLETED PHASE1

A Study to Learn How Renal Impairment Affects the Pharmacokinetics of PF-07817883.

NCT06586216

COVID-19

COMPLETED PHASE1

Pharmacokinetic Assessment of Single-Dose Odanacatib (MK-0822) in Subjects With Severe Renal Insufficiency (MK-0822-067)

NCT01512667

Renal Insufficiency

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

End Stage Renal Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Regimen A: Oseltamivir with HD

Participants will receive 30 milligrams (mg) of oseltamivir via oral suspension approximately 1 hour after alternating HD sessions. Sessions will occur three times per week within the 6.5-week study period, and participants will receive a total of 9 doses of oseltamivir.

Group Type EXPERIMENTAL

Oseltamivir

Intervention Type DRUG

Oseltamivir will be given as marketed oral suspension, 30 mg after HD or CAPD treatment.

Regimen B: Oseltamivir with CAPD

Participants will receive 30 mg of oseltamivir via oral suspension once weekly after dialysis exchange. CAPD sessions will occur four times every 24 hours, and participants will receive a total of 6 doses of oseltamivir within the 6-week study period.

Group Type EXPERIMENTAL

Oseltamivir

Intervention Type DRUG

Oseltamivir will be given as marketed oral suspension, 30 mg after HD or CAPD treatment.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Oseltamivir

Oseltamivir will be given as marketed oral suspension, 30 mg after HD or CAPD treatment.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Tamiflu

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adults greater than or equal to (\>/=) 18 years of age
* ESRD defined as no residual renal function or a creatinine clearance (CrCl) less than (\<) 10 milliliters per minute (mL/min)
* Well established HD or CAPD therapy over a period of 3 months with stable CrCl \< 10 mL/min
* Body mass index (BMI) 18 to 34 kilograms per meter-squared (kg/m\^2)
* Use of contraception among women of childbearing potential

Exclusion Criteria

* Clinical significant comorbid disease or terminal illness
* Known human immunodeficiency virus (HIV) or hepatitis B or C
* History of drug or alcohol abuse within the prior year
* Donation or loss of \>/= 400 milliliters (mL) of blood in the 3 months prior to Screening
* Participation in a clinical study with an investigational drug in the 3 months prior to study drug
* Pregnant or lactating women

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No